IJCRR - 13(19), October, 2021
Pages: 178-182
Human Palatability Study for Taste Assessment of Marketed Formulation of Second-Generation Antipsychotic Drug Asenapine Maleate: The Present Scenario and Scope of Improvement
Author: Gupta Niraj, Mahapatra Abikesh Prasada Kumar, Ekambaram Vijay Kumar, Padhy Saubhagya Kumar
Category: Healthcare
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Abstract:
Introduction: Asenapine maleate, a second-generation atypical antipsychotic drug, used for the medical management, pharmacotherapy of bipolar 1 disorder and schizophrenia had been already discussed and well-established in the scientific domain. A number of scientific research findings and post-marketing studies have claimed the efficacy of the marketed formulation SAPHRIS® (Asenapine maleate) sublingual tablet in combating schizophrenia and bipolar mania. The sublingual administration of SAPHRIS® has both positive and negative effects. Medication discontinuation is more prevalent due to bitter taste of the medication thus negatively impacting the patient acceptability and compliance to dosage regimen. Objective: In the current study, we technically evaluate the palatability and patient compliance of the marketed formulation SAPHRIS® (Asenapine maleate) sublingual tablet. We have also recommended the most relevant formulation technology that can be implemented to further enhance palatability of Asenapine maleate having an outcome similar to SAPHRIS® marketed sublingual tablet formulation. Methods: Human volunteers were used to evaluate taste perception of Asenapine maleate drug substance and its marketed formulation SAPHRIS® (Asenapine maleate) tablet by human sensory evaluation test. Bitterness scale (Score 1 to 4) was used for the evaluation of bitterness level in SAPHRIS® (Asenapine maleate) Sublingual tablet and Asenapine maleate. Results: In the present study, bitterness and patient acceptability of the marketed sublingual tablet formulation of asenapine maleate SAPHRIS® was evaluated by the human sensory evaluation test. The study results revealed that Asenapine is bitter in taste but barely acceptable however its marketed formulation SAPHRIS® is bitter in taste but acceptable. Effort was given to provide the techniques available in the research domain along with suitable hydrophilic excipients that can be used to further completely mask the bitter taste in formulation. Conclusion: In conclusion, we opined that there is a need for improvement in the taste of the currently available marketed sublingual tablet dosage form of Asenapine maleate. The study also explores the relevant techniques that can be used to increase palatability among patients.
Keywords: Asenapine maleate, Antipsychotic drug, Sublingual tablet, SAPHRIS®, Taste perception, Patient compliance, Bitterness.
Citation:
Gupta Niraj, Mahapatra Abikesh Prasada Kumar, Ekambaram Vijay Kumar, Padhy Saubhagya Kumar. Human Palatability Study for Taste Assessment of Marketed Formulation of Second-Generation Antipsychotic Drug Asenapine Maleate: The Present Scenario and Scope of Improvement International Journal of Current Research and Review. 13(19), October, 178-182
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